Trial Outcomes & Findings for Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study (NCT NCT03481725)
NCT ID: NCT03481725
Last Updated: 2021-03-18
Results Overview
Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point measured in morphine equivalents
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Postoperative days 0-7
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
Peripheral Nerve Stimulation
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
Sham
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
34
|
|
Overall Study
COMPLETED
|
30
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Peripheral Nerve Stimulation
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
Sham
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 16 • n=31 Participants
|
55 years
STANDARD_DEVIATION 16 • n=34 Participants
|
56 years
STANDARD_DEVIATION 16 • n=65 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=31 Participants
|
17 Participants
n=34 Participants
|
32 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=31 Participants
|
17 Participants
n=34 Participants
|
33 Participants
n=65 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
34 participants
n=34 Participants
|
65 participants
n=65 Participants
|
|
Height
|
172 cm
STANDARD_DEVIATION 11 • n=31 Participants
|
174 cm
STANDARD_DEVIATION 10 • n=34 Participants
|
173 cm
STANDARD_DEVIATION 10 • n=65 Participants
|
|
Weight
|
80 kg
STANDARD_DEVIATION 16 • n=31 Participants
|
86 kg
STANDARD_DEVIATION 20 • n=34 Participants
|
83 kg
STANDARD_DEVIATION 18 • n=65 Participants
|
|
Body Mass Index
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=31 Participants
|
29 kg/m^2
STANDARD_DEVIATION 5 • n=34 Participants
|
28 kg/m^2
STANDARD_DEVIATION 5 • n=65 Participants
|
|
Years of education
|
17 years
STANDARD_DEVIATION 3 • n=31 Participants
|
16 years
STANDARD_DEVIATION 3 • n=34 Participants
|
17 years
STANDARD_DEVIATION 3 • n=65 Participants
|
|
Enrolling Center
Cedars-Sinai
|
1 Participants
n=31 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=65 Participants
|
|
Marital Status
Single
|
9 Participants
n=31 Participants
|
9 Participants
n=34 Participants
|
18 Participants
n=65 Participants
|
|
Marital Status
Currently Married
|
18 Participants
n=31 Participants
|
23 Participants
n=34 Participants
|
41 Participants
n=65 Participants
|
|
Marital Status
Others (separated and widowed)
|
4 Participants
n=31 Participants
|
2 Participants
n=34 Participants
|
6 Participants
n=65 Participants
|
|
Military Status
Civilian (never in military)
|
23 Participants
n=31 Participants
|
29 Participants
n=34 Participants
|
52 Participants
n=65 Participants
|
|
Military Status
Veteran
|
8 Participants
n=31 Participants
|
3 Participants
n=34 Participants
|
11 Participants
n=65 Participants
|
|
Military Status
Active Duty
|
0 Participants
n=31 Participants
|
2 Participants
n=34 Participants
|
2 Participants
n=65 Participants
|
|
Enrolling Center
University California San Diego
|
28 Participants
n=31 Participants
|
28 Participants
n=34 Participants
|
56 Participants
n=65 Participants
|
|
Enrolling Center
Naval Medical Center San Diego
|
0 Participants
n=31 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=65 Participants
|
|
Enrolling Center
Walter Reed National Military Medical Center
|
1 Participants
n=31 Participants
|
2 Participants
n=34 Participants
|
3 Participants
n=65 Participants
|
|
Enrolling Center
Womack Army Medical Center
|
1 Participants
n=31 Participants
|
2 Participants
n=34 Participants
|
3 Participants
n=65 Participants
|
|
Surgical Procedure
Rotator cuff repair
|
13 Participants
n=31 Participants
|
8 Participants
n=34 Participants
|
21 Participants
n=65 Participants
|
|
Surgical Procedure
Anterior cruciate ligament reconstruction
|
1 Participants
n=31 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=65 Participants
|
|
Surgical Procedure
Ankle arthrodesis
|
4 Participants
n=31 Participants
|
7 Participants
n=34 Participants
|
11 Participants
n=65 Participants
|
|
Surgical Procedure
Ankle arthroplasty
|
4 Participants
n=31 Participants
|
5 Participants
n=34 Participants
|
9 Participants
n=65 Participants
|
|
Surgical Procedure
Hallux valgus
|
9 Participants
n=31 Participants
|
11 Participants
n=34 Participants
|
20 Participants
n=65 Participants
|
|
Surgical side
Left
|
10 Participants
n=31 Participants
|
19 Participants
n=34 Participants
|
29 Participants
n=65 Participants
|
|
Surgical side
Right
|
21 Participants
n=31 Participants
|
15 Participants
n=34 Participants
|
36 Participants
n=65 Participants
|
|
General anesthetic
|
27 Participants
n=31 Participants
|
28 Participants
n=34 Participants
|
55 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Postoperative days 0-7Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point measured in morphine equivalents
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Opioid Consumption During First Postoperative Week
|
47.5 mg
Interval 25.0 to 90.0
|
5.0 mg
Interval 0.0 to 30.0
|
PRIMARY outcome
Timeframe: Postoperative days 0-7Mean value of the "average" pain scores measured using the numeric rating scale, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Average Pain During First Postoperative Week
|
3.1 score on a scale
Standard Deviation 1.7
|
1.1 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4Cumulative opioid dose of previous 24 hours (measured in morphine equivalents)
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Opioid Consumption Individual Time Points
Postoperative Day 15
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Opioid Consumption Individual Time Points
Postoperative Day 1
|
15 mg
Interval 0.0 to 20.0
|
0 mg
Interval 0.0 to 100.0
|
|
Opioid Consumption Individual Time Points
Postoperative Day 2
|
20 mg
Interval 10.0 to 30.0
|
5 mg
Interval 0.0 to 10.0
|
|
Opioid Consumption Individual Time Points
Postoperative Day 3
|
10 mg
Interval 0.0 to 20.0
|
0 mg
Interval 0.0 to 0.0
|
|
Opioid Consumption Individual Time Points
Postoperative Day 4
|
5 mg
Interval 0.0 to 20.0
|
0 mg
Interval 0.0 to 0.0
|
|
Opioid Consumption Individual Time Points
Postoperative Day 7
|
0 mg
Interval 0.0 to 10.0
|
0 mg
Interval 0.0 to 0.0
|
|
Opioid Consumption Individual Time Points
Postoperative Day 11
|
0 mg
Interval 0.0 to 5.0
|
0 mg
Interval 0.0 to 0.0
|
|
Opioid Consumption Individual Time Points
Postoperative Month 1
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Opioid Consumption Individual Time Points
Postoperative Month 4
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Postoperative days 3, and 7; as well as Months 1 and 4The Brief Pain Inventory (short form) interference domain is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0 = no interference; 10 = complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The score is calculated by adding the responses for each individual question resulting in a possible range of 0-70 (higher = worse).
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Domain)
Postoperative Day 3
|
21.5 units on a scale
Standard Deviation 17.9
|
2.6 units on a scale
Standard Deviation 4.5
|
|
Brief Pain Inventory, Short Form (Interference Domain)
Postoperative Day 7
|
19.0 units on a scale
Standard Deviation 17.0
|
2.5 units on a scale
Standard Deviation 4.9
|
|
Brief Pain Inventory, Short Form (Interference Domain)
Postoperative Month 1
|
6.2 units on a scale
Standard Deviation 10.4
|
4.0 units on a scale
Standard Deviation 7.7
|
|
Brief Pain Inventory, Short Form (Interference Domain)
Postoperative Month 4
|
5.8 units on a scale
Standard Deviation 12.3
|
1.6 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4Mean of the "average" pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Average Pain at Individual Time Points
Postoperative Day 1
|
4.0 score on a scale
Standard Deviation 2.6
|
1.8 score on a scale
Standard Deviation 1.8
|
|
Average Pain at Individual Time Points
Postoperative Day 2
|
3.9 score on a scale
Standard Deviation 2.1
|
1.3 score on a scale
Standard Deviation 1.4
|
|
Average Pain at Individual Time Points
Postoperative Day 3
|
3.1 score on a scale
Standard Deviation 2.3
|
0.9 score on a scale
Standard Deviation 1.2
|
|
Average Pain at Individual Time Points
Postoperative Day 4
|
2.3 score on a scale
Standard Deviation 2.0
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Average Pain at Individual Time Points
Postoperative Day 7
|
1.9 score on a scale
Standard Deviation 2.1
|
0.6 score on a scale
Standard Deviation 1.1
|
|
Average Pain at Individual Time Points
Postoperative Day 11
|
1.7 score on a scale
Standard Deviation 1.4
|
0.3 score on a scale
Standard Deviation 0.2
|
|
Average Pain at Individual Time Points
Postoperative Day 15
|
1.9 score on a scale
Standard Deviation 1.6
|
0.9 score on a scale
Standard Deviation 0.6
|
|
Average Pain at Individual Time Points
Postoperative Month 1
|
1.3 score on a scale
Standard Deviation 1.8
|
0.5 score on a scale
Standard Deviation 0.8
|
|
Average Pain at Individual Time Points
Postoperative Month 4
|
0.8 score on a scale
Standard Deviation 1.7
|
0.3 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4Median of the worst pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Worst Pain at Individual Time Points
Postoperative Day 1
|
7.8 score on a scale
Interval 3.0 to 9.0
|
4 score on a scale
Interval 0.0 to 6.0
|
|
Worst Pain at Individual Time Points
Postoperative Day 2
|
7.5 score on a scale
Interval 5.0 to 9.0
|
4 score on a scale
Interval 2.0 to 6.0
|
|
Worst Pain at Individual Time Points
Postoperative Day 3
|
6 score on a scale
Interval 4.0 to 8.0
|
3 score on a scale
Interval 0.0 to 4.0
|
|
Worst Pain at Individual Time Points
Postoperative Day 4
|
4.3 score on a scale
Interval 3.0 to 7.0
|
1.3 score on a scale
Interval 0.0 to 4.0
|
|
Worst Pain at Individual Time Points
Postoperative Day 7
|
3.5 score on a scale
Interval 3.0 to 5.0
|
1.8 score on a scale
Interval 0.0 to 3.5
|
|
Worst Pain at Individual Time Points
Postoperative Day 11
|
3 score on a scale
Interval 1.0 to 5.0
|
0.5 score on a scale
Interval 0.0 to 2.0
|
|
Worst Pain at Individual Time Points
Postoperative Day 15
|
2 score on a scale
Interval 0.0 to 4.5
|
1.0 score on a scale
Interval 0.0 to 5.0
|
|
Worst Pain at Individual Time Points
Postoperative Month 1
|
2 score on a scale
Interval 0.0 to 4.0
|
3.0 score on a scale
Interval 0.0 to 4.0
|
|
Worst Pain at Individual Time Points
Postoperative Month 4
|
1.5 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Postoperative days 3 and 7; as well as Months 1 and 4Least pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Participants were asked "what was the lowest pain within the last 24 hours measured using the 0 to 10 scale, with 0 equal to no pain and 10 equal to the worst imaginable pain"?
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Least Pain at Individual Time Points
Postoperative Day 3
|
1.4 score on a scale
Standard Deviation 1.8
|
0.2 score on a scale
Standard Deviation 0.6
|
|
Least Pain at Individual Time Points
Postoperative Day 7
|
0.7 score on a scale
Standard Deviation 1.6
|
0.2 score on a scale
Standard Deviation 0.7
|
|
Least Pain at Individual Time Points
Postoperative Month 1
|
0.5 score on a scale
Standard Deviation 1.0
|
0.1 score on a scale
Standard Deviation 0.3
|
|
Least Pain at Individual Time Points
Postoperative Month 4
|
0.4 score on a scale
Standard Deviation 1.2
|
0.3 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Postoperative days 3 and 7; as well as Months 1 and 4Current pain scores at the time of the data-collection phone call measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Current Pain at Individual Time Points
Postoperative Month 1
|
1.0 score on a scale
Standard Deviation 1.8
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Current Pain at Individual Time Points
Postoperative Month 4
|
0.4 score on a scale
Standard Deviation 0.9
|
0.1 score on a scale
Standard Deviation 0.6
|
|
Current Pain at Individual Time Points
Postoperative Day 3
|
2.3 score on a scale
Standard Deviation 2.3
|
0.4 score on a scale
Standard Deviation 0.7
|
|
Current Pain at Individual Time Points
Postoperative Day 7
|
1.5 score on a scale
Standard Deviation 2.2
|
0.3 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Postoperative days 3, and 7; as well as Months 1 and 4Instrument designed to assess pain level specifically for active duty military and Veteran patient populations. It is a Likert scale from 0 (no pain) to 10 (worst imaginable pain).
Outcome measures
| Measure |
Sham
n=34 Participants
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
Peripheral Nerve Stimulation
n=31 Participants
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
|---|---|---|
|
Defense and Veterans Pain Rating Score
Postoperative Day 3
|
4.2 score on a scale
Standard Deviation 2.3
|
1.4 score on a scale
Standard Deviation 1.5
|
|
Defense and Veterans Pain Rating Score
Postoperative Day 7
|
2.9 score on a scale
Standard Deviation 2.5
|
1.1 score on a scale
Standard Deviation 1.5
|
|
Defense and Veterans Pain Rating Score
Postoperative Month 1
|
1.5 score on a scale
Standard Deviation 2.0
|
1.3 score on a scale
Standard Deviation 1.4
|
|
Defense and Veterans Pain Rating Score
Postoperative Month 4
|
1.2 score on a scale
Standard Deviation 1.7
|
0.6 score on a scale
Standard Deviation 1.4
|
Adverse Events
Peripheral Nerve Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peripheral Nerve Stimulation
n=31 participants at risk
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that DOES generate electric current for 14 days
|
Sham
n=34 participants at risk
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator that does NOT generate electric current for 14 days
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lead fracture during purposeful removal
|
3.2%
1/31 • Number of events 1 • 4 months following surgery
|
2.9%
1/34 • Number of events 1 • 4 months following surgery
|
|
Musculoskeletal and connective tissue disorders
Adhesive reaction
|
3.2%
1/31 • Number of events 1 • 4 months following surgery
|
0.00%
0/34 • 4 months following surgery
|
Additional Information
Brian M. Ilfeld, MD, MS
University of California San Diego
Phone: (858) 822-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place